Blister package with electronic content monitoring system

ABSTRACT

A replicate can be secured to a blister package intended to contain articles, such as pills, and is used to record the removal of individual articles from the blisters. To remove an article from a blister one will usually press against the blister to push the article through a frangible closure seal, breaking the seal in the process. The replicate includes a backing sheet which carries a plurality of traces alignable with corresponding blisters so that when the article is removed from the blister it will not only break the seal but it will also break the corresponding trace. All of the traces are connected to an integrated circuit which may also be formed or provided on the backing sheet, as is a power source for the integrated circuit. The breaking of the trace is an event that is recorded in the integrated circuit for later accessability. The replicate may be secured to the blister package after the package has been produced by conventional form-fill-seal equipment. The individual traces can be formed into a grid of closely spaced traces so that alignment of the traces with the individual blisters is less critical. The replicates may be formed by printing or other conventional methods on a roll of lidstock. After forming the individual replicates are severed from the roll of lidstock for securement to a blister package.

CROSS-REFERENCE TO RELATED APPLICATION

This is a filing under 35 U.S.C. 371 of PCT/CA02/2023, filed Dec. 30,2002, which claims priority from Canadian Application Serial No.2,366,887, filed Dec. 31, 2001. PCT/CA02/2023 has been published asInternational Publication Number WO 03/055769, and the publication is inEnglish.

FIELD OF THE INVENTION

This invention relates to a packaging device and a content usemonitoring system and, more particularly, to a preformed backing sheetcarrying electronic circuitry for use with a packaging device and acontent use monitoring system that is primarily adapted to medicationpackaging and dispensing.

BACKGROUND OF THE INVENTION

Medications comprise a large component of health care. A limiting factorto the effectiveness of many medications is patient compliance with theprescriptions. Medications typically must be taken at specific intervalsbased on their pharmacokinetics to maximize plasma levels, and anysubstantial deviation from the prescribed interval may result inineffectiveness or adverse effects. As the patient population ages, theincidence of medication errors increases.

A prior invention by Wilson and Petersen as disclosed in Canadian PatentApplication No. 2,353,350 of Jul. 20, 2001 describes a packaging devicefor monitoring use of the contents of blister packages. The packagingdevice comprises a package, an electrically conducting path and anelectronic chip embedded in, or supported by, the package. The packagehas one or more sealable receptacles for accommodating contents. Theelectrically conducting path is associated with each receptacle. Itchanges its characteristics when the receptacle is opened after beingsealed. The electronic chip monitors the change in the characteristicsof the conducting path, and generates content use data when the changein the characteristics of the conducting path is detected.

One practical difficulty with the Wilson and Petersen invention is thatthe electronic traces which establish the electronic path must beoriented accurately relative to the blisters or receptacles, between thecontents and the lidstock or backing. A second difficulty lies inconnecting the electrical traces to the electronic chip, whichincorporates an integrated circuit (IC). A third-difficulty lies in thenecessity of redesigning widely used form-fill-seal machines to carryout these functions.

It is desirable to have a simpler solution to the integration ofelectronic monitoring devices with the blister package, preferably sothat widely existing form-fill-seal machines can still be used withlittle or no modification thereto.

SUMMARY OF THE INVENTION

The present invention relates specifically to the mounting of replicatesof an electronic inventory control device for blister packaging on rollsof lidstock (backing) which can then be used to seal blister packagedmedications or other contents by standard form-fill-seal devices.

The invention comprises replicates of a suitable integrated circuit(IC), a power source, and an electrically conducting trace systemmounted on lidstock in such a way that the lidstock can be used withstandard or only slightly modified form-fill-seal machinery to form ablister package. Each replicate encompasses an area of lidstock ofdimensions appropriate for the desired blister package. On either thetop or the bottom surface of the lidstock is located a pattern or a gridof electrically conducting traces each ultimately terminating at acontact of the IC, which has its own power supply, clock andnon-volatile memory, and which is also attached to the lidstock. Whenattached to the package, each trace in one embodiment is designed tocorrespond to or to intersect a single blister of the package. When thecontents of the blister are expelled though the backing the associatedtrace is broken. The IC tests the integrity of the traces at specifiedintervals and records the time of detection of a newly broken trace inthe non-volatile memory.

In a second embodiment of the invention the traces are arranged in agrid without concern as to having each trace intersect a single blister.The grid is composed of a relatively large number of traces such thatseveral traces of the grid will intersect each blister. When thecontents of a blister are expelled therefrom the grid, rather than anindividual trace, would be broken, causing a change in the resistance ofthe circuitry. This change in resistance would be recorded in thenon-volatile memory of the IC as a timed event. By using the gridarrangement the need to align individual traces with the blisters isobviated and the positioning of the replicate relative to the packagebecomes less critical to effective operability. A replicate using a gridarrangement would have more universal applicability as the same designcould be used with a large variety of different packages.

The information can be retrieved from the IC's memory at a later time byany suitable means, such as a non-contact reader, and displayed oranalyzed as required.

Other aspects and features of the present invention will be readilyapparent to those skilled in the art from a review of the followingdetailed description of preferred embodiments in conjunction with theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be further understood from the following descriptionwith reference to the drawings in which:

FIG. 1. Is a perspective view showing a roll of lidstock with aplurality of replicates of this invention thereon;

FIG. 2. Is a schematic view of a single replication of the integratedcircuit and electrically conducting traces;

FIG. 3. Is a schematic view of a single replication of the integratedcircuit and electrically conducting traces in relation to the positionof the blisters;

FIG. 4. Is schematic cross sectional view of the blister packageincluding the backing with its integrated circuit and electricallyconducting traces;

FIG. 5 is a rear perspective view of another form of blister packageincorporating the present invention;

FIG. 6 is a front view of the rear flap of the package of FIG. 5 with areplicate of the present invention thereon;

FIG. 7 is a partially broken away front view of the package of FIG. 5showing the replicate captured between two layers of the rear flap ofthe package; and

FIG. 8 is a schematic representation of a single replicate of thisinvention with an electrically-conducting grid associated therewith.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring to FIG. 1, replicates 10 of the electronic inventory controldevice of this invention are attached to a roll 12 of backing (lidstock)designed for blister packaging. FIG. 2 depicts a first embodiment of theinvention wherein each replicate 10 comprises a network of electricallyconducting traces 14 terminating on the contacts 16 of an integratedcircuit (IC) 18 containing a power supply, clock, and non-volatilememory (not shown). The traces 14 are oriented so that each tracecorresponds to the position of a blister 20 (FIG. 3) and so thatexpelling the contents of the blister through the backing will break thetrace. At programmed intervals, the IC 18 samples the integrity of thetraces and records the time that a broken trace is detected in itsnon-volatile memory.

The replicates can be mechanically attached to the backing 12, printedon the backing 12 (as by silk screening for example), or a combinationof both techniques can be used. They can be located on either surface ofthe backing 12 (i.e.: inside or outside in reference to the blisterpackage). The backing 12 may be a single sheet of material as shown orit may be a multi-layered laminate. In the event that a laminate isused, the traces may be sandwiched between layers of the laminate.

The IC 18 may be, but is not limited to, a standard smart card ICattached to the backing 12 in such a way as to have its terminalcoincide with the ends of the electrically conducting traces 14. It mayalso be printed on the lidstock using emerging thin-film technology.

The power supply may be, but is not limited to, an integral part of theIC 18. It may be of conventional design as used for smart cards andsimilar applications or it may be printed directly on the backing. TheIC can be of the digital or the analog variety and can employ volatilememory as well as the preferred non-volatile memory mentioned herein.The IC can be adapted for use with infrared, and radio frequency,proximity and contact reader systems to facilitate the downloading ofevent information as recorded in the memory of the IC.

The traces 14 can be made of any electrically conducting materialaffixed to or printed on the backing.

Also included in the invention is the use of an adhesive lidstock thatcan be applied to the back of an already finished blister package toallow for inventory control as described using already packagedcontents.

FIGS. 5 and 6 illustrate another type of package that can benefit fromthe present invention. Therein a foldable package 20 has a front flap 22which may carry product information, a spine 24 to which the front flapis attached along fold line 26, and a second or rear flap 28 which ishingedly attached to the spine 24 along fold line 30. The rear flap 28carries a plurality of blisters or receptacles 32 on the inside surfacethereof, which blisters are normally protected by the front flap 22. Theoutside surface of the rear flap has a plurality of openings 34therethrough in alignment with the blisters 32, each opening beingcovered by a thin layer 36 of a frangible material. Secured to,preferably, the inside surface of the rear flap is a replicate 38 of thepresent invention which includes an electronic chip 18′ incorporating anintegrated circuit, a power source and a non-volatile memory, and aplurality of traces 14′ which intersect the blisters 32. The chip andthe traces will be protected by the front flap 22 in the normalcondition of the package.

When the front flap is lifted the blisters are exposed and the contentsof a selected blister can be pushed through the frangible material 36 atthe rear surface. Preferably, as shown, the traces 14′ will intersectthe openings 34 such that each trace intersecting an opening will bedisrupted when the contents of the associated blister are pushed throughthe frangible material 36. This causes the detectable change incharacteristics referenced hereinabove, which change is stored in thenon-volatile memory for later downloading.

If the rear flap of the package is formed of more than one layer ofmaterial then the replicate carrying the electronic chip 18′ and thetraces 14′ could be located between two of the layers so that it wouldbe hidden from view. This is shown in FIG. 7 wherein it is seen that theblisters 40 are secured to the inside surface 42 of the rear panel 44 ofthe rear flap and project through openings 46 in the front panel 48 ofthe rear flap. The replicate 38 is in turn secured to, preferably, theinside surface 42 of the rear panel 44 so that it is sandwiched orcaptured between the front and rear panels 44, 48 during final assemblyof the package as it flows through a form-fill-seal packaging machine.

While the IC 18′ is illustrated in FIGS. 6 and 7 as being located on thesame flap 28 as the traces 14′ and the blisters 32 it could just aseasily be located on the flap 22, separated from the blisters andconnected via traces which extend over the spine 24 to the traces 14′which intersect the blisters. This configuration would be used when theentire flap 28 is covered by blisters and there is no room on or in theflap for the IC itself.

FIG. 8 illustrates yet another embodiment of the present inventionwherein the individual traces 14, 14′, which must be positioned so thateach intersects a corresponding blister, are replaced by a finemesh-like grid 50. The grid 50 is made up of sets of electricallyconducting traces 52, 54 with the traces 52 intersecting the traces 54at right angles. The spacing between individual traces within each setis considerably less than the spacing between traces in the otherembodiments, the result being that each blister will overly several ofthe traces making up the sets 52, 54. The sets 52, 54 are in turnconnected by traces 56, 58 to the IC 18″. Whenever the contents of anindividual blister are expelled therefrom the plurality of tracestherebelow will be ruptured, causing a change in the resistance of thecircuit, which change is recorded in the non-volatile memory of the IC18″ for later downloading. With this embodiment the need to accuratelyalign blisters and traces, to ensure that each blister is associatedwith a corresponding single trace is obviated.

The foregoing has described the present invention and several means ofputting the invention into effect. It is understood that the inventioncan be effected in a multitude of different ways without departing fromthe spirit of the invention. Accordingly the protection to be affordedthis invention is to be determined from the scope of the claims appendedhereto.

1. A replicate for application to a blister package containing aplurality of articles, each in an individual blister such that each sucharticle can be projected through a corresponding portion of the packageand the replicate for removal from the package, said replicate includinga frangible backing sheet, an integrated circuit on said backing sheet,a power source for the integrated circuit, means for attaching saidreplicate to said package, and a plurality of individual electricallyconductive traces on said backing sheet, said traces defining a gridpattern of intersecting sets of parallel such traces, said traces beingpositioned on said backing sheet so that more than one thereof willintersect each of said blisters when said replicate is attached to saidpackage, said intersecting sets of traces being connected to saidintegrated circuit, whereby when an article is projected from itsblister through said replicate the corresponding traces are broken, soas to define an event that can be recorded by said integrated circuit.2. The replicate of claim 1 wherein said integrated circuit includes aclock and a non-volatile memory, whereby a time associated with eachevent can be recorded in said memory for retrieval at a later point intime.
 3. The replicate of claim 1 wherein said power supply is integralwith said integrated circuit.
 4. The replicate of claim 1 wherein saidintegrated circuit and said traces are printed on said backing sheet. 5.The replicate of claim 1 wherein an adhesive is applied to said backingsheet for attachment of said replicate to said blister package.
 6. Thereplicate of claim 1 wherein a cover sheet is applied to said replicatewith said integrated circuit and said conductive traces sandwichedbetween said cover sheet and said backing sheet to create a laminatedreplicate.
 7. A blister package comprising: a sheet of material having aplurality of openings therethrough; a plurality of individual flexibleblisters mounted to one surface of said sheet, each of said blistersbeing in registry with a corresponding opening; an article located ineach of said blisters; a closure seal formed of frangible materialextending across each said opening so as to hermetically capture thearticle in the corresponding blister; a replicate secured to theopposite surface of said sheet, said replicate including; a frangiblebacking sheet; an integrated circuit on said backing sheet; a powersource for the integrated circuit; means for attaching said replicate tosaid opposite surface; and a plurality of individual electricallyconductive traces on said backing sheet, said traces defining a gridpattern of intersecting sets of parallel such traces; said intersectingsets of traces being positioned on said backing sheet so that more thanone thereof will intersect a corresponding one of said closure sealswhen said replicate is attached to said package, said intersecting setsof traces being connected to said integrated circuit, whereby when anarticle is projected from its blister through said closure seal and saidreplicate the corresponding traces are broken, so as to define an eventthat can be recorded by said integrated circuit.
 8. A blister packagecomprising: a sheet of material having a plurality of openingstherethrough; a plurality of individual flexible blisters mounted to onesurface of said sheet, each of said blisters being in registry with acorresponding opening; an article located in each of said blisters; aclosure seal formed of frangible material extending across each saidopening so as to hermetically capture the article in the correspondingblister; a replicate secured to said one surface of said sheet, saidreplicate including: a frangible backing sheet; an integrated circuit onsaid backing sheet; a power source for the integrated circuit; means forattaching said replicate to said one surface; and a plurality ofindividual electrically conductive traces on said backing sheet, saidtraces defining a grid pattern of intersecting sets of parallel suchtraces; said sets of intersecting traces being positioned on saidbacking sheet so that more than one thereof will intersect acorresponding one of said blisters when said replicate is attached tosaid package, said intersecting sets of traces being connected to saidintegrated circuit, whereby when an article is projected from itsblister through said closure seal and said replicate the correspondingtraces are broken, so as to define an event that can be recorded by saidintegrated circuit.
 9. The package of claim 8 including a cover sheetthrough which said blisters project, said cover sheet being applied tosaid one surface of said backing material so as to capture saidreplicate between itself and said one surface of said backing material.10. A blister package comprising: a first flap, a second flap, and aspine hingedly attached to each of said first and second flaps; aplurality of individual flexible blisters mounted to an inside surfaceof said second flap; a plurality of openings extending through a rearsurface of said second flap, each of said openings being in registrywith a corresponding blister; an article located in each of saidblisters; a closure seal formed of frangible material extending acrosseach said opening so as to hermetically capture the article in thecorresponding blister; a replicate secured to said inside surface ofsaid second flap, said replicate including: a frangible backing sheet;an integrated circuit; a power source for the integrated circuit; meansfor attaching said replicate to said second flap; and a plurality ofindividual electrically conductive traces on said backing sheet, saidtraces defining a grid pattern of intersecting sets of parallel suchtraces; said sets of intersecting traces being positioned on saidbacking sheet so that more than one thereof will intersect acorresponding one of said blisters when said replicate is attached tosaid second flap, said intersecting sets of traces being connected tosaid integrated circuit, whereby when an article is projected from itsblister through said closure seal and said replicate the correspondingtraces are broken, so as to define an event that can be recorded by saidintegrated circuit.
 11. The package of claim 10 wherein said integratedcircuit is provided on said backing sheet.
 12. The package of claim 10wherein said integrated circuit is provided on said first flap.